-100% Cotton Fabric. There are 3 classifications under ASTM International standards: Level 1 (low) - venous pressure splash; Level 2 (moderate) - arterial pressure splash; Level 3 (high) - high-velocity procedures, orthopedic surgery; Unlike N95 respirators, medical masks are looser in fit. 4-Layer, 4-fold Level 3. High breathability. Ready-to-ship masks at wholesale prices and custom printed face masks available. 21. F1862 sets the standard for this type of testing as well as for the creation of the synthetic blood used in the test. CERTIFICATION: Product is ASTM Certified Level 1 per ASTM standards for Level 1 Face Masks. 4 Ply ASTM Level III Surgical Mask Description: Maximum fit, filtration and comfort. Why are there so many? Medical Grade Surgical Face Mask ASTM F2100 - 11 Standard - Level 3 Certified Electrostatically Charged Melt Blown Filtration Layer Sub-Micron Particulates Filtration Efficient ≥99% at 0.1 micron Bacterial Filtration Efficiency ≥99% Ear Loops to fit securely Nose Strip to ensure no gaps Pleats to expand the mask Its skin-friendly non-woven fabric is gentle on human skin & has low breathing … ASTM International is providing no-cost public access to important ASTM standards used in the production and testing of personal protective equipment - including face masks, medical gowns, gloves, and hand sanitizers - to support manufacturers, test labs, health care professionals, and the public, as they respond to the global COVID-19 public health emergency. Click “Access” below, register if you are a new user to our reading room, and then you may access and download a PDF of the standards relevant to the global health pandemic. … > PRIMED ASTM Level 3 Disposable Face Masks - Blue - 50 Pack Find a PRIMED ASTM Level 3 Disposable Face Masks - Blue - 50 Pack at Staples.ca. Face mask labels. ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus, ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks, ASTM F2100-19E01 Spécification normalisée pour la performance des matériaux utilisés dans les masques médicaux, ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity), ASTM F1494-14 Standard Terminology Relating to Protective Clothing, ASTM F3407-20 Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators, ASTM F2407 - 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities, ASTM F1671 / F1671M - 13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, ASTM F1868 - 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate, ASTM D751 - 19 Standard Test Methods for Coated Fabrics, ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics, ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles, ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test), ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure, ASTM D5733 - 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008), ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers, ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application, ASTM D3578-19 Standard Specification for Rubber Examination Gloves, ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application, ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application, ASTM E2755-15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults, ASTM E1174-13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations, ASTM E3058-16 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations, ASTM E1838-17 Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults, ASTM E2613-14 Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults, ASTM E2870-19 Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling, ASTM E2011-13 Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand, ASTM F3387-19 Standard Practice for Respiratory Protection, ASTM E1104-98 Standard Specification for Clinical Thermometer Probe Covers and Sheaths. ASTM levels 1, 2, and 3 are all required to be Class 1 flame resistant. This standard applies specifically to the synthetic blood penetration testing that’s designed to mimic the real-world situations in which the masks are used, according to Smith. Standards labelled “EN” are for the EU. The best thing about this medical face mask is that it has the highest fluid resistance rating, which is level 3, according to the American Society for Testing and Materials (ASTM). Aureus (average size 0.6-0.8 microns). This standard is important for evaluating the ability of a mask to keep aerosol droplets – caused by talking, coughing, and sneezing ­– away from the wearer’s mouth and nose. BFE ≥ 98%, PFE ≥ 98%; Note: cloth masks offer 20% filtration effectiveness and will not filter out small viral particles found in exhaled respiratory droplets. Tim Sprinkle is a freelance writer based in Colorado Springs, Colorado. -Certified to new CDC guidelines. In recent weeks, the topic of protective clothing has become very much mainstream, with these products entering broader use outside of hospitals and healthcare facilities in response to COVID-19. A standard that has received a great deal of attention in worldwide media recently, this test measures the sub-micron particulate filtration efficiency, and is required for medical face masks in case healthcare procedures generate small particles. Latex and fiberglass free. feature product on sale now. Bonus Chin Strip. We wish to give away 1 million face masks in the next month! Moderate and high protection masks must have bacterial filtration rates greater than 98%. Copyright © 1996 - 2021 ASTM. Medical face masks are intended to resist liquid penetration based on a number of different factors, including the surface tension and viscosity of the fluids themselves, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. $10.99$10.99($0.22/Count)$15.99$15.99. ASTM sets labeling requirements for certified masks, giving them a “stamp of approval” that people could look for on packaging while shopping, explained Adalja. Middle: 100% Melt blown fabrics. If a mask has ASTM labeling, it means that it meets testing and quality requirements outlined by ASTM. When it is solely a matter of micromillimeters, level up your mask ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA, Enter the email ids seperarted by comma for e.g one@test.com,two@test.com, Full List of ASTM International Standards Made Available at No Charge. It will also show the mask’s ability to prevent aerosols from the wearer's mouth from reaching the environment. The Mask Lab 3 Ply Surgical Face Mask - International ASTM Level 3 Certified for virus, dust, airborne particles, pollution (3 layer medical grade mask for men and women): Amazon.in: Clothing & Accessories This test is particularly sensitive, detecting viral penetration using a biological assay technique where visual penetration may not occur, and is usually performed on surgical gowns. ASTM International is providing no-cost public access to important ASTM standards used in the production and testing of personal protective equipment - including face masks, medical gowns, gloves, and hand sanitizers - to support manufacturers, test labs, health care professionals, and the public, as they respond to the global COVID-19 public health emergency. $34. ASTM-CERTIFIED DISPOSABLE MASK. PENN Protective Equipment is a Canadian 3 layer medical face mask manufacturer and PPE distributor located in Cambridge, Ontario. The bacteria used is Staphylococcus aureus, which is attached to liquid droplets with sizes ranging from 0.65–9 microns and above with 3 microns as the mean particle size. As we are seeing with the the COVID-19 outbreak, viruses can be very resilient, and extensive precautions must be taken to protect medical professionals and patients from potential transmission in a hospital setting. VIEW PRODUCTS. Ultra fluid and splash resistant inner and outer layer. READ MORE: Full List of ASTM International Standards Made Available at No Charge. Face masks, gowns, and other articles of protective clothing are in high demand as people seek to avoid spreading or contracting the novel coronavirus. This type of face covering, officially known as an ASTM F2100 Level 3 Surgical Mask, is gaining a reputation as something of a contender in the world of protective face masks. Global Collaboration to Advance Personal Protective Equipment (PPE) Safety, Quality, and Innovation. Personal protective equipment has played a key role in the response to COVID-19. According to Smit, medical face mask material performance is based on testing for bacterial filtration efficiency (F2101), differential pressure (EN 14683), sub-micron particulate filtration efficiency (F2299), resistance to penetration by synthetic blood (F1862), and flammability (16 CFR Part 1610). In this case, the test is designed to determine whether or not the mask would effectively protect a surgeon from blood spatter. PFE exceeds 99%. Read reviews to learn about the top-rated PRIMED ASTM Level 3 Disposable Face Masks - Blue - 50 Pack. Fluid resistant. ASTM levels represent performance classes for face mask materials as bacterial filtration efficiency (ASTM F2101), sub-micron particulate filtration efficiency (ASTM F2299), differential pressure (MIL-M-36954C), fluid penetration resistance (ASTM F1862) and flammability (16 CFR Part 1610) [8]. Testing criteria are as follows. STANDARD ATTACHMENT DESIGN: Elastic Ear Loops (17.5cm X 9.5cm) COMPONENT: Outer & Inner: 100% Non-woven fabrics. The ASTM F2100 Level 2 Rated Masks are Ideal for use in procedures Involving Moderate Levels of Spray, Splatter and Airborne Particles, 50 Pieces/Box (Pink) We work hard to protect your security and privacy. VIEW PRODUCTS. In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Certified products would carry a label statement that the products meet the ASTM F3502 specification for barrier face coverings. The standard has been created to evaluate only consumer masks. We help shockproof the North American medical PPE market by providing Made in Canada ASTM certified masks. According to Smit, this test is used to determine penetration in protective clothing using a very small virus, the Phi-X174 bacteriophage. A filtration efficiency is then reported: This is the ratio of the amount of bacterial aerosols challenging the mask versus the amount that was able to penetrate the mask. It is possible for a generic manufacturer, such as a garment factory, to become a surgical mask manufacturer, but there are many challenges to overcome. Extra soft and comfortable. MASK CONSTRUCTION: Sonic Welded. ASTM Level 3 Ultra™ Sensitive FogFree™ Earloop Mask w/ Shield w/ Secure Fit™ Mask Technology Ideal for procedures where heavy to moderate amounts of fluid, spray and or aerosols are produced. Get it as soon as Mon, Mar 15. Many other countries will have their own rating systems too. ASTM F2100 Level 3 is made to fit comfortably for extended use with high breathability and filtration needed for patient care. Unipack Medical Corporation 9830 Norwalk Blvd, Suite: 100, Santa Fe Springs, CA 90670 Tel: 562-777-8000 Fax: 562-777-8005 Email: info@unipackmedical.com ASTM Level 3 Disposable 4-Ply Face Mask - Made in USA - Certified by Eurofins and Nelson Labs | 4 Layer Masks with Filtration Efficiency >=98% - Graphite Gray (50 PCS) 4.3 out of 5 stars. 3M is a company that manufactures masks. The biological subcommittee develops and maintains standards that are meant to protect healthcare workers or the healthcare environment from biological hazards that can cause infection. An ASTM-certified F3502 mask needs a mask protection efficiency score of 50% to be considered High Performance under new CDC NIOSH guidelines. Subcommittee on antimicrobial agents' guidance on viruses that may be used in SARS-CoV-2 research focusing on environmental survival and decontamination strategies. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. F3502−21 Standard Specification for Barrier Face Coverings. The intended use for medical face masks is to protect the wearer from splashes or sprays during healthcare procedures, as well as keeping large splashes and sprays from the wearer from reaching the environment. ASTM F2100 (NIOSH) is for the US. facial protection, you can select an ASTM-rated mask that is right for you and protects the best. ASTM Level 3 Procedural Mask, internationally certified quality material. The difference in protection between a Level 2 mask and a Level 3 mask is minimal. ASTM Level 3 Medical Certified; PFE exceeds 99%; 4-ply, 4-fold Level 3; Extra soft and comfortable; High breathability; Fluid resistant; Latex and fiberglass free; Bonus Chin Strip ; IMPORTANT: The filtration efficiency and protective ability of a face mask is compromised when the mask becomes wet, torn or … As a … Filtration Feel Fluid resistance Features Fit Bonus Comfort & Breathability Level Up! Can Any Manufacturer Become a Surgical Mask Manufacturer? ASTM Level 1 Masks are the standard for surgical masks. FREE Shipping on orders over $25 shipped by Amazon. He has written for Yahoo, The Street, and other websites. Sarah Smit, chair of the biological subcommittee, recently identified the most important standards for protective personal equipment (PPE), listed below. SKU: GURD-AM303. AIRE Premium Disposable Face Mask - 3 Ply Protection - ASTM Level 1 Medical Grade Procedure Masks - Soft & Strong Earloops, Bendable Nose Wire BLUE, 1 Box (50) 4.2 out of 5 stars67. The air flow resistance needs to be less than or equal to 5 millimeters of water column. These devices may be used by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. 3M Masks? Each box contains 10 Lion, 10 Puppy, 10 Rabbit and 10 Teddy Bear masks. All Rights Reserved. This includes the new F3502-21 Barrier Face Covering standard. Our ASTM certified designer masks exceed the CDC's upcoming mask guidelines for reusable fabric masks, providing industry-leading filtration and comfort. FLUID RESISITANCE, mmHg: 80 COLOR: Blue. Our voluntary programs are based on globally-recognized standards, including ASTM, ANSI, CSA, NFPA, NIJ, and NOCSAE. The intended use for medical face masks is to protect the wearer from splashes or sprays during healthcare procedures, as … In light of COVID-19 (coronavirus) and ongoing safety concerns for members and staff, changes to meetings, standards development, training, and more, have been announced. These standards are among many that ASTM International has made available at no charge in order to support manufacturers, test labs, health care professionals, and the general public as they respond to the global COVID-19 public health emergency. PM2.5 vs. N95. Mask is waterproof, breathable, and soft on face. 130+ top companies from all over the world come to SEI for their product certification needs. Click here to see these updates. Per FDA guidance, the particle size is 0.1 microns and the particles are non-neutralized for medical face masks. For every 10 face masks sold, CovCare is donating one disposable 3-ply face mask to a hospital in need. FDA has developed this guidance document to assist industry in preparing premarket notification submissions for surgical masks and other masks including isolation masks, procedure masks, and dental masks. You will be asked to login at no cost to you. According to Smit, medical face mask material performance is based on testing for bacterial filtration efficiency , differential pressure (EN 14683), sub-micron particulate filtration efficiency , resistance to penetration by synthetic blood , and flammability (16 CFR Part 1610). Mask does not contain ferromagnetic materials or latex. [Pack of 50] FDA Certified, Disposable 3-Ply Surgical Medical Face Mask (ASTM Level 3) from 27.99. sale. All of these products fall under the purview of ASTM International’s committee on personal protective clothing and equipment (F23) and its subcommittee on biological (F23.40). ASTM Level 3. What are ASTM Testing Methods for Medical Face Masks? Healthcare workers wear face masks to prevent germs from their noses and mouths from passing to the patient as well as to protect themselves from infection. Our payment security system encrypts your information during transmission. GUARDIS 4-Ply ASTM Level 3 Disposable Mask. SEI certified companies receive: 1. annual product testing of certified safety and protective equipment 2. annual quality assurance audits at the manufacturer’s facility 3. confidence that your product meets the most current comprehensive standards on the market It is usually performed on drapes. 3D DISPOSABLE MASK. They generally produce masks that meet KN95 or N95 standards. Note: F1670 is similar standard that uses synthetic blood for testing and is a visual penetration test. Each product lot is tested and certified to exceed international standards for surgical masks. Our PPE is ASTM certified medical-grade for front-line workers and professionals. $34.99. Easy to breathe with full width adjustable nose piece. Level 2 ASTM-certified masks will have to show that they filter out at least 50% of these particles. As we now know, N95 is a mask rating. As part of the complete Cardinal Health facial protection offering, they are a cost-effective solution for general use, particularly in low-fluid cases. Disposable Face Mask. However, the label must state the products are not a medical mask or a respirator. The scrubs and gowns they wear serve similar purposes, protecting healthcare workers as well as patients from the accidental transmission of disease, as do the drapes that are used during surgery. Specifications (ASTM 2100): Bacterial filtration efficiency: ≥98% Sub-micron particulates filtration efficient at 0.1 micro